Investigation and impact of transitional care program from hospital to home on the quality of life of women with breast cancer and the care burden of their caregivers in two intervention and control groups.
Design
A clinical trial with a control group, with parallel groups, not blinded, randomized based on a block of four on 60 patients, due to the lack of drug use, the phase is not valid.
Settings and conduct
This study is a randomized controlled clinical trial that will be conducted on women undergoing mastectomy in selected military centers (Baqiyatullah Aj Hospital and Chamran Hospital). They will be randomly divided into two intervention and control groups using the quadruple block method. Transitional care program in the intervention group will start from the time the patient is admitted and will continue until three months after discharge from the hospital. Also, training will be given to the patient in four sessions (one session before surgery and three sessions once a week until three weeks after discharge for 45 minutes).
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients one to three days after mastectomy
Having the age of eighteen to seventy years
Breast cancer identified by pathology and treated by surgery
Ability to complete the questionnaire independently
Access to home phone and mobile phone
Not suffering from mental illnesses
Exclusion criteria
History of chronic diseases
Not living in Tehran
Women over seventy years old
Intervention groups
Intervention group: Transitional care program will start from the time of admission of the patient and will continue until three months after discharge from the hospital.
Control group: they will go through the usual process of discharge from the hospital (providing an educational brochure, containing educational tips after the operation)
Main outcome variables
Quality of life, caregiver burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231203060248N1
Registration date:2023-12-23, 1402/10/02
Registration timing:prospective
Last update:2023-12-23, 1402/10/02
Update count:1
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Marzie sadat Seyed alighadr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6552 7557
Email address
marziealighadr25@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transitional care program from hospital to home on the quality of life of women with breast cancer their family caregiver’s burden
Public title
The effectiveness of transitional care program on the quality of life of women with breast cancer and the care burden of their caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients one to three days after mastectomy
Breast cancer identified by pathology and treated by surgery
Ability to complete the questionnaire independently
Access to home and mobile phones
Residence in Tehran and its suburbs within one month after discharge for the possibility of home visits
No mental illness
Exclusion criteria:
History of chronic diseases
Women over seventy years old
Non-residence of the person in Tehran
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial that will be conducted on women undergoing mastectomy in selected military centers. At first, the samples will be randomly divided into intervention and control groups based on the inclusion criteria and selected in a purposeful way and by the quadruple block method. The method of random assignment with blocks of four will be such that letter A will be assigned to the intervention group and letter B will be assigned to the control group, and in blocks of four with letters A and B, six states AABB, BBAA, ABAB, BABA , ABBA, BAAB will be written on separate sheets and thrown in a container. Randomly, one of these sheets will be taken out of the container and the composition written on it will be noted and that sheet will be thrown into the container again. Since the sample size is 60 patients, this procedure will be repeated fifteen times and each time the composition written on the sheet will be noted down after the composition written on the previous sheet. Then, each letter will be assigned a number from one to sixty in the order of the letters written down one after the other. Each of the letters will be placed in an envelope and numbers from one to sixty will be written on the envelope. Each time a patient is selected, one of these envelopes will be opened in order of the number written on the envelope, and it will be determined in which group the patient will be placed. And after explaining the objectives of the study and obtaining verbal and written informed consent, the people of the control group of the usual process of discharge from the hospital (providing an educational brochure, containing educational tips after the operation, as well as answering questions that some patients randomly asked the researcher or department personnel will be asked) and the researcher will only complete the demographic profile questionnaire with regard to these people by asking them and the information of the patients' files. Also, in the intervention group, the transitional care program will be carried out based on transitional care components and Nanda's nursing diagnoses.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics and Research Committee of Baqiyatullah Azam Educational-Therapeutic Center
Street address
South Bahai Sheikh, Nosrati Alley, Baqiyatullah Aj University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.082
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the start of the intervention) and three months after the intervention
Method of measurement
Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)
Secondary outcomes
1
Description
The care burden of the caregivers
Timepoint
At the beginning of the study (before the start of the intervention) and three months after the intervention
Method of measurement
Zarit Care Burden Assessment Questionnaire
Intervention groups
1
Description
The transitional care plan is the coordination and continuity of medical care during the transfer of the patient from one care complex to another complex or home. Care sets, care providers, conditions and care needs in the acute and chronic period of the disease change in this transition period. Supporting the patient during the transition from one phase of illness or treatment to another, such as moving from receiving care in the hospital to care at home, is one of the goals of transitional care. And in the intervention group, it will start from the time the patient is admitted and will continue until three months after discharge from the hospital. Also, trainings will be given to the patient during four sessions (one session before surgery and three sessions once a week until three weeks after discharge for 45 minutes). The researcher will meet the patient eligible to enter the study in the first 24 hours of admission, and after announcing the readiness of the patient and the caregivers to enter the study, they will complete the demographic profile questionnaire and the quality of life and care burden of the caregivers. After the discharge, the researcher will contact the patients or their home caregiver once a week until the end of the intervention and will check the progress of the disease and the achievement of the goals. The time of the first appointment will be determined within seven to ten days after discharge. The duration of phone conversations will change based on the client's needs. The last phone call will be made with the patient in the twelfth week after discharge, during which, in addition to counseling, the necessary coordination for the second and last meeting with the patient will also be done. After the completion of the intervention (twelfth week after discharge), the quality of life and caregiver burden questionnaire will be completed again in both groups by the researcher and during the meeting with the patient. The answers will be analyzed and compared.
Category
Other
2
Description
Control group: After explaining the objectives of the study and obtaining verbal and written informed consent, the people in the control group were given the usual process of discharge from the hospital (providing an educational brochure, containing post-operative educational tips, as well as answering questions that some patients randomly ask the researcher or staff asked) and the researcher will only complete the demographic profile questionnaire with regard to these people by asking them and the information of the patients' files.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah AJ Hospital, Chamran Hospital
Full name of responsible person
Dr. Akram Parandeh
Street address
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 912 515 7599
Email
akram.parandeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hassan Abul Qasimi
Street address
South Sheikh Baha'i, Nosrati Street, Baqiyatullah AJ University
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 0000
Email
Pchd1391@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Sadat Seyyed Aliqader
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 6448 2797
Email
marziealighadr25@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Sadat Seyyed Aliqader
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 6448 2797
Email
marziealighadr25@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Marzieh Sadat Seyyed Aliqader
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 6448 2797
Email
marziealighadr25@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after de-identifying individuals
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
All people have permission to access data and documents
Under which criteria data/document could be used
Access to the outcomes and results of this study will help others to use transitional care to choose the most effective work on the quality of life of women with breast cancer and the care burden of their caregivers.
From where data/document is obtainable
To receive the data, send an email to the address below
marziealighadr25@gmail.com
What processes are involved for a request to access data/document